Jul 22, 2022

Japan’s Ministry of Health, Labour and Welfare (MHLW) has updated its guidance on documents that medical device market registrants must submit when applying for a quality management system (QMS) Conformity Survey.

What documents are manufacturers required to submit with a QMS Conformity Survey?

Several notices (links in Japanese) from MHLW explain these revised requirements. First, a new piece of guidance updates the list of documents that manufacturers must submit when applying for a QMS Conformity Assessment using the Gateway System. Only Japanese Market Authorization Holders (MAHs) and manufacturers can access the Gateway System.

Second, MHLW has updated its guidance notes on how manufacturers must submit their documents when applying for a QMS Conformity Survey.

As we have previously reported, before the MHLW joined the Medical Device Single Audit Program (MDSAP) as a participating regulator, Japanese market registration required manufacturers to comply with MHLW Ordinance 169 for QMS. The aim of MDSAP is to create harmonized medical device standards to increase patient safety while easing the administrative compliance burden on manufacturers.

Emergo by UL will continue to post updates to MHLW guidance as they are released.

Additional Japanese medical device regulatory resources from Emergo by UL:

  • Medical Device Gap, Internal, Pre-Certification and Supplier QMS Audits consulting
  • Quality Management System Compliance with Japan Ordinance 169 services
  • Medical Device Classification Consulting and Japan JMDN Code Research consulting
  • Whitepaper: Japan's New QMS Conformity Assessment System
  • Whitepaper: Medical Device Change Applications in Japan


  • Kathryn Burke's picture
    Kathryn Burke